Should charge variants of monoclonal antibody therapeutics be considered critical quality attributes?-Reference-Cited by-同舟云学术

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Should charge variants of monoclonal antibody therapeutics be considered critical quality attributes?

Published:2016-08-09 Issue:17-18 Volume:37 Page:2338-2346
ISSN:0173-0835
Container-title:ELECTROPHORESIS
language:en
Short-container-title:ELECTROPHORESIS

Author:

Singh Sumit Kumar¹,Narula Gunjan¹,Rathore Anurag S.¹

Affiliation:

1. Department of Chemical Engineering; Indian Institute of Technology Delhi; Hauz Khas New Delhi India

Funder

Department of Biotechnology , Ministry of Science and Technology

Publisher

Wiley

Subject

Clinical Biochemistry,Biochemistry,Analytical Chemistry

Reference31 articles.

1. Biosimilars and the long game

2. Follow-on protein products: scientific issues, developments and challenges

3. Establishing analytical comparability for “biosimilars”: filgrastim as a case study

4. Charge variants in IgG1

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1. Coupling cation and anion exchange chromatography for fast separation of monoclonal antibody charge variants;Journal of Chromatography A;2024-09

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3. LC–MS Characterization and Stability Assessment Elucidate Correlation Between Charge Variant Composition and Degradation of Monoclonal Antibody Therapeutics;The AAPS Journal;2024-04-03

4. Countercurrent preferential precipitation of acidic variants from monoclonal antibody pools;Chemical Engineering Research and Design;2024-02

5. Overcoming Complex Analytical Challenges Posed by Targeted Multispecific Antibody Cancer Therapeutics;LCGC North America;2023-10-01

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